CN113134122A - Apparatus, system and method for storing, processing and/or processing blood and blood components - Google Patents

Abstract

The present invention relates to apparatus, systems and methods for storing, processing and/or processing blood and blood components, including methods and systems for automated identification, processing devices with scanners, blood containers with two-dimensional barcodes, blood collection containers, blood container labels and related tracking methods, integrated container systems, and processing devices with sterile connection devices.

Description

Apparatus, system and method for storing, processing and/or processing blood and blood components

This application is a divisional application of the chinese application having application number 201680053344.6, filed 2016, 9, month 13, entitled "apparatus, system, and method for storing, processing, and/or processing blood and blood components.

Cross Reference to Related Applications

This application claims us provisional application 62/218,214 filed on 9, 14/2015; us provisional application 62/218,234 filed on 9/14/2015; and priority and benefit of U.S. provisional application 62/218,242 filed on 14/9/2015, each of which is incorporated herein by reference.

Technical Field

The present application relates generally to the storage, processing and/or processing of blood and blood components, and related novel devices, systems and methods associated with such storage, processing and/or processing.

Background

It is well known to collect whole blood from donors using manual collection procedures, such as by blood donation activities, donor-to-blood center or hospital blood donations, and the like. In such procedures, blood is typically collected by simply allowing the blood to flow from the donor into a collection container (e.g., a flexible pouch or bag) under the force of gravity and venous pressure. However, various blood collection devices may be used to assist or facilitate the collection of blood or blood components.

The collection container in manual collection is typically part of a larger pre-assembled arrangement of tubing and containers (sometimes referred to as satellite containers) for further processing of the collected whole blood. More specifically, whole blood is typically first collected in a so-called primary collection container that also contains an anticoagulant such as, but not limited to, a solution of sodium citrate, phosphate, and dextrose (CPD).

After initial collection, it is common practice to transport the collected whole blood to another facility or location, sometimes referred to as a "post-laboratory," for further processing. This process typically requires manual loading of the main collection container and associated tubing and satellite containers into a centrifuge to separate the whole blood into concentrated red blood cells and platelet-rich or platelet-poor plasma. The separated components may then be discharged from the main collection vessel into one or more satellite vessels, and the red blood cells combined with an additive or preservative solution pre-filled in one of the satellite vessels. One such additive solution includes sodium chloride, mannitol, adenine and dextrose, such as that sold under the trademark Fenwal corporation of lake Zurich, Ill

And (4) selling. After the above steps, the blood components may be centrifuged again, if necessary, for example to separate platelets from plasma. As will be apparent from the present description, this process is labor intensive, time consuming, and prone to human error.

Efforts have been made to automate the equipment and systems used in the post-collection processing of whole blood, and more recently it has been proposed to use an automatic blood component separator to perform such post-collection processing. While many existing blood separation devices and procedures employ the principle of centrifugation, there is another class of devices that employ relatively rotating surfaces, at least one of which is provided with a porous membrane.

Such systems may include a membrane covered spinner having an internal collection system disposed within a stationary housing or shell. Alternatively, the inner surface of the stationary housing may be covered by a membrane, or both the spinner and the housing may include an associated membrane. For the purposes of this specification, these will be referred to as membrane separators. In such membrane separators, blood is fed into an annular space or gap between the spinner and the housing and moves along the longitudinal axis of the housing toward an outlet region. The plasma passes through the membrane and exits through the outlet port, while the remaining cellular blood components (red blood cells, platelets, and white blood cells) remain in the gap and move to exit the region between the spinner and the housing through the outlet port. It has been found that membrane separators provide excellent plasma filtration rates, primarily due to the unique flow patterns ("taylor vortices") induced in the gap between the rotating membrane and the housing. The taylor vortex helps prevent blood cells from depositing on the membrane and contaminating or clogging the membrane. Detailed descriptions of membrane separators can be found in U.S. Pat. Nos. 5,194,145, 4,776,964, 4,753,729, and 5,135,667, all of which are incorporated herein by reference.

Although membrane separators have been widely used for collecting plasma, they have not generally been used for collecting other blood components, particularly red blood cells. One example of a membrane separator for collecting separated red blood cells is described in PCT patent application publication No. WO 2014/039086 a1, which is incorporated by reference herein in its entirety. Further, systems employing such membrane separators for whole blood collection post-processing are described in U.S. patent application No. 14/677,319 filed on 4/2/2015, also incorporated herein by reference in its entirety.

The subject matter disclosed herein provides further advances in various aspects of devices, systems, and methods that can be used in whole blood collection and collection post-processing systems, but they are not necessarily limited to such systems. Examples of existing devices or methods can be found in U.S. patent No. 9,038,823 and U.S. published patent application No. US 2012/0269679.

Disclosure of Invention

There are several aspects of the present subject matter that may be implemented separately or together in the apparatuses, systems, and methods described and/or claimed below. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the use of these aspects alone or the protection of these aspects alone or in various combinations as described in the claims appended hereto or as subsequently modified. For the purposes of the present specification and claims, unless expressly stated otherwise, "blood" is intended to include whole blood and blood components such as concentrated red blood cells, plasma, platelets, and white blood cells, whether with or without anticoagulants or additives. Moreover, the words "imager," "scanner," "imaging," "scanning," "imager/scanner," and "scanner/imager" and variations thereof are used interchangeably and interchangeably in this specification and, unless explicitly stated otherwise, without any distinction, to refer to a device that optically observes or reads an image, such as a bar code, logo, label or portion of a label on a blood container and/or a method employed by the device for non-exclusive purposes of retrieving or capturing information, whether such information is in the form of data encoded into a bar code, the actual image itself, information or data reflected in such an image, or information or data derivable from such an image, or any combination thereof.

The following summary is provided to familiarize the reader with various potential aspects of the present subject matter in general, and is non-limiting and non-exclusive with respect to various possible aspects or combinations of aspects. Additional aspects and features may be found in the detailed description and/or figures herein.

Authentication/imaging

In one aspect, a method for automated identification of blood component containers is provided. The method comprises the following steps: scanning a commercial logo carried on a wall of a container; detecting one or more characteristics of the scanned logo and comparing the one or more characteristics to one or more established reference characteristics of the commercial logo on the authentic blood component container; and determining whether the scanned container is genuine based on the comparison of the determined one or more features with the established one or more reference features. The method is preferably performed automatically by a programmable controller associated with the blood processing apparatus. In the event that a non-genuine container is determined to be used, an alarm may be generated and/or operation of the processing device may be disabled.

In a related aspect, a system may be provided that includes a disposable blood or blood component processing circuit and a durable blood processing set cooperatively associated with the processing circuit for controlling flow through the processing circuit. The processing circuit includes a blood or blood component container having a commercial logo carried on an exterior surface of the container. The processing device includes: a scanner configured to optically scan the logo when a container is cooperatively associated with the device; and a programmable controller configured to receive signals from the scanner. The controller is programmed to: detecting one or more features of the optically scanned logo; the one or more features are compared to an established reference feature or features of a commercial logo on a genuine blood component container, and a determination is made as to whether the scanned container is genuine based on the comparison of the determined one or more features to the established reference feature or features. The scanner may also capture an image of the logo and save or transmit it to a data storage device for future reference and/or as part of a process record.

In a further independent aspect, there is provided a processing device for processing a medical fluid, such as blood or a blood component, the processing device comprising a housing, container suspension means for suspending a container from the processing device, and a scanning system for scanning at least a portion of a surface of the container facing the suspension means when the container is suspended from the suspension means. The scanning system includes: a window in the housing adjacent the location of the container when the container is suspended from the suspension means; and a scanner located within the housing and positioned to scan or image a surface of the suspended container through the window. The scanner is positioned to image a selected surface area of the container. The selected surface area may be a label carried on the container, and the label may include, but is not limited to, a bar code, a commercial logo as outlined above, and/or other information or images.

Bar code/identification

In one aspect, a blood container is provided that carries a two-dimensional barcode on an exterior surface of the container. The barcode may encode at least the manufacturer's part number or catalog number of the particular blood container. It may also include other information, such as the expiration date of the blood container. The blood container is preferably configured to be suspended from the blood processing device, and the barcode is located on a side of the container facing the blood processing device when the container is suspended from the blood processing device. This allows a scanner on the device to scan the bar code to obtain the encoded information. The encoded information may include all manufacturing-related information for the blood and blood components to be contained in the container that is required by the united states industry consensus standard for uniform identification of blood and blood components.

In yet another aspect, a whole blood collection container for collecting whole blood from a donor is provided. The container includes a wall having an outer surface, a first panel substantially permanently affixed to the outer surface of the container wall, a second panel removably affixed to the first panel, the second panel being removable from the first panel for transfer and attachment to a surface of a separate blood component container. The second panel has an outer surface carrying a plurality of removable identification panels, each identification panel being removable for transfer and attachment to a third container, and each third panel carrying a unique tracking identifier.

In another aspect, a blood container label is provided that includes a first panel including oppositely facing first and second surfaces, the first surface including an adhesive for attachment to a blood container. The label also includes a second panel removably carried on the second surface of the first panel. The second panel carries a plurality of removable identification panels, each identification panel including a first surface for attachment to a blood container and an opposite facing surface carrying a unique donation identification number.

In a related aspect, a method for tracking blood or blood components is provided. The method includes substantially permanently attaching a first panel to an exterior surface of a whole blood container for collecting whole blood from a donor, and removably attaching a second panel smaller than the first panel to the exterior surface of the first panel. The second panel carries a plurality of removable identification panels, each of which is removable for transfer and attachment to another container, and each of which carries a unique tracking identifier.

Blood container/processing device and system

In one aspect, a single blood collection container is provided, the container comprising: a pair of facing flexible plastic sheets sealed together along a sealing line to define an interior cavity for receiving blood, the interior cavity having a first end, a second end, a first side, and a second side. The inlet and outlet ports extend at the first end through a sealing line for flowing blood into and out of the container, the sealing line being uninterrupted except for the inlet and outlet ports. An inlet conduit is connected to the inlet port and extends to the distal or second end for connection to a vascular access member. The outlet conduit has a first end connected to the outlet port and a second end sealed to maintain sterility for sterile connection to blood processing equipment by a sterile connection device on the blood processing apparatus. The single blood collection container may be used with any of the aspects outlined below, alone or in combination, and the following aspects may be used independently with other containers, systems, or methods.

In accordance with another aspect of the present subject matter, a blood collection container is provided that includes a pair of facing flexible plastic sheets sealed together along a sealing line to define an interior cavity for receiving blood, the cavity having a first end, a second end, a first side and a second side. The inlet and outlet ports extend through the seal line at either the first or second end for flow of blood into and out of the container, and the hanging hole is located on at least one of the first and second sides.

In another aspect, an integrated container system may be provided that includes a pair of facing flexible plastic sheets sealed together to define at least two separate internal cavities, one for receiving blood and the other pre-filled with a selected amount of red blood cell additive fluid. Each cavity is defined by a separate seal line extending around the respective cavity, and each cavity includes a first end, a second end, a first side, and a second side. The containers are integrally connected by a plastic web extending between the sides of the cavity. The blood chamber inlet port and the blood chamber outlet port extend through respective blood chamber sealing lines at the first end of the blood chamber for flow of blood into and out of the container, and the sealing lines are uninterrupted except for the inlet port and the outlet port. The additive fluid chamber inlet port and the additive fluid chamber outlet port extend through the additive fluid chamber seal line at the first end of the additive fluid chamber, and the seal line is uninterrupted except for the inlet port and the outlet port.

According to another aspect, a durable blood processing apparatus is provided for cooperative association with a disposable blood or blood component processing circuit including a plurality of individual processing circuit modules for cooperative mounting on the processing apparatus, wherein one of the modules includes a rotatable blood separator and the processing apparatus includes a receiving station for the rotatable blood separator and a drive system at the station for rotating the separator. At least two of the process circuit modules each comprise a thermoplastic fluid flow conduit section and the process device comprises aseptic connection means for receiving and automatically connecting said conduit sections to each other in an aseptic manner, so that fluid flows through said conduit sections upon activation of said device by a user.

These and other aspects of the present subject matter are set forth in the detailed description of the following drawings.

Drawings

Fig. 1A is a perspective view of a blood processing system employing a reusable durable portion and a disposable fluid flow circuit formed from a plurality of fluid flow subsystems or modules.

Fig. 1B is a perspective view of the blood processing system of fig. 1 from a different perspective.

FIG. 2 is a front view of a single whole blood collection container.

FIG. 3 is a front view of an integrated whole blood collection container and additive solution container.

Fig. 4 is a flow chart depicting a blood or blood component container labeling system and method of use thereof.

Fig. 5 is a flow chart depicting another blood or blood component container labeling system and method of use thereof.

Fig. 6 is a flow chart depicting yet another blood or blood component container labeling system and method of use thereof.

FIG. 7 is a diagrammatic perspective view of a blood or blood component container having a two-dimensional bar code and a scanner for scanning the bar code.

Fig. 8 is a diagrammatic perspective view of a blood or blood component container having a commercial logo and a scanner for scanning the commercial logo.

Fig. 9 is a diagrammatic cross-sectional view of a medical fluid processing device, such as the blood processing device of fig. 1A and 1B, showing the positioning of a scanner in the processing device.

Detailed Description

Blood processing system

FIG. 1 depicts a blood processing system, generally designated 10, particularly a post-collection blood processing system, including a durable, reusable processing set 12 and a disposable fluid flow circuit 14 for processing collected whole blood. The illustrated blood processing set 12 includes associated pumps, valves, sensors, displays and other devices for configuring and controlling the flow of blood and additive solutions through the disposable circuit. The apparatus and process may be directed by an internal controller comprising a programmable microprocessor that automatically controls the operation of pumps, valves, sensors, etc.

More specifically, the processing set-up shown includes a user input and output touch screen 16, a pump station including a whole blood pump 18, an RBC pump 20, and an additive solution pump 22, a blood separator mounting station and drive unit 24, a leukocyte cell filter housing 26, tubing clamps/RF sealers/sensors 28a-d, sterile connection or docking sets 30a-b, tubing clamps 32a-b, a hematocrit sensor 34, and a container scanner 36. The processing device further comprises hangers 38a-d, each associated with a weighing scale, for suspending the various containers of the disposable fluid circuit.

As shown, the fluid flow circuits are provided in three separate modules, each of which is individually preassembled and joined together on the processing device. These modules are: (i) an additive solution module comprising a prefilled additive solution container 40 and an associated fluid flow line 42 for withdrawing additive solution, (ii) a whole blood module comprising at least a whole blood container 44 and an associated fluid flow line 46 for withdrawing collected whole blood from the container, and (iii) a processing module comprising a pump cassette 48, a membrane separator 50, a Red Blood Cell (RBC) container 52, a plasma container 54, a leukocyte removal filter 56 (located within housing 26 as shown) and associated connecting lines. Pump cassette 48 directs fluid flow through three tubing loops extending from the cassette, and each loop is uniquely positioned to engage a particular one of pumps 18-22. The tubing may extend through the cassette, or the cassette may have a preformed fluid flow path that directs the fluid flow. The membrane separator employs a membrane covered rotor within a stationary housing as previously described to separate plasma from cellular components of whole blood and is rotated by a magnetic drive unit associated with the mounting station 24.

The modules are individually positioned on the processing device 12. With respect to the whole blood module, a whole blood container 44 is suspended from the scale hanger 38a at the front of the processing device, and an associated fluid flow conduit 46 extends from the lower end of the whole blood container through the hematocrit sensor 34, the conduit clamp 32a, to the sterile connection device 30a, where the fluid flow conduit 46 ultimately joins the conduit from the processing module.

With respect to the additive solution module, an additive solution container 40 is suspended from a weigh scale hanger 38b on the side of the processing apparatus, and an associated fluid flow conduit 42 extends from the lower end of the additive solution container through the additive fluid conduit clamp 32b to the aseptic connection device 30b, where the fluid flow conduit 42 will join with the conduit from the processing module.

Turning to the process module, a membrane separator 50 is positioned in association with the separator mounting/drive station 24. The fluid flow is directed through the pump cassette 48 for pump control, the pump cassette 48 being mounted at the pump stations PS adjacent the pumps 18-22 such that the tubing loop extending from the pump cassette is positioned in registry with, and preferably for automatic feeding onto, one of the particular pumps 18-22. A whole blood tubing section 58 extends from the cassette to the sterile connection device 30b for automatic connection to the tubing 46 associated with the whole blood container 44. The whole blood tubing section or its flow path continues through the cassette, forming an external tubing loop for cooperation with the whole blood pump 18 (shown as a rotary peristaltic pump), and then continues from the cassette to the whole blood inlet 60 of the membrane separator 50.

The membrane separation device separates whole blood into plasma and a red blood cell concentrate (which may include other cellular components such as platelets and white blood cells). From the separator, the plasma is directed into a pre-attached plasma container 54, which plasma container 54 is suspended on the weigh scale hanger 38c in front of the processing device 12. To allow plasma to flow from the membrane separator 50 into the plasma container, a tubing section 62 connects the plasma container and the plasma outlet 64 of the membrane separator and extends through the clamp/sealer/sensor 28 a.

Packed Red Blood Cells (RBCs) flow from the membrane separator 50 through a red blood cell outlet port 66 of the membrane separator and through a red blood cell fluid flow tubing section 68 into the pump cassette 48. The red blood cell tube segment 68 continues to the cassette and forms an outer tube loop for cooperation with the red blood cell pump 20. The red blood cell tubing section continues up from the cassette and to a leukoreduction filter 56, which leukoreduction filter 56 removes white blood cells from the red blood cell concentrate. The RBC tubing section extends from the leukopheresis filter through the clamp/sealer/sensor 28b and into the red blood cell storage container 52, the red blood cell storage container 52 being suspended from the weight scale cradle 38d on the side of the processing device.

To help maintain the viability of the red blood cells, additive solution from additive solution container 40 is added to the red blood cell container. Specifically, the additive solution flow conduit 42 is connected by the aseptic connection device 30b to an additive flow conduit section 70 that is part of the process module. The pipe section 70 extends to the box 48 and the additive solution flows through an external loop in cooperation with the additive solution pump 22. Downstream of the pump 22, the additive solution flows into the RBC flow path (tubing section 68 or pre-formed flow path) within the cassette, where it mixes with the RBCs. Thereafter, the combined additive solution and RBCs flow through the RBC tubing section 68 to the filter 56 and into the container 52.

The tubing section 72 extends between the cassette 48 (where the tubing section 72 is in communication with the RBC flow path) and the RBC storage container 52, generally parallel to the RBC tubing section 68. The sections are filled with blood from the container and sealed at spaced apart locations by a blood processing person to provide a series of blood filled "sections" that can be subsequently severed for sampling, testing or cross-matching.

The tubing section 72 also provides a passageway that allows residual air to be removed from the RBC container after processing is complete. A pump may be used to pump residual air from the RBC container through tubing section 72 to the empty whole blood container and ultimately back to the whole blood container 44.

The conduit section 72 has an additional benefit. It can be used to flow RBCs directly into the RBC container 52 and bypass the filter 56. This is particularly useful in cases where RBCs cannot be filtered, for example for known physiological reasons, such as in donors with sickle cell anemia. For those cases, the filter may be bypassed and plasma may still be processed and collected.

As noted above, in the illustrated embodiment, the disposable fluid circuit 14 is assembled from separate modules, and sterile connection (sometimes referred to as sterile docking) devices 30a-b are provided to connect the fluid flow conduits of the different modules. The aseptic coupling device may employ any of several different operating principles. For example, known aseptic connection devices and systems include: a radiant energy system to melt facing membranes of fluid flow conduits, as described in U.S. patent No. 4,157,723; a heated wafer system that employs wafers to cut and thermally bond or splice the pipe sections together while the ends remain molten or semi-molten, as in U.S. patent nos. 4,753,697, 5,158,630, and 5,156,701; and systems employing removable closure films or webs sealed to the ends of the duct sections, as described in U.S. patent application publication No. 2014/0077488. All of the above patents are incorporated herein by reference in their entirety.

More recently, systems have been disclosed that use different techniques to form aseptic connections, wherein sealed pipe sections are compressed or pinched, heated, and the sealed ends are severed. The pipe is then joined to a similarly treated pipe section. A detailed description of this type of device can be found in U.S. patent application publication No. 2013/0153048 and U.S. patent application No. 14/309,305 filed 6/19 2014, both of which are incorporated herein by reference in their entirety. This type of sterile connection arrangement is particularly contemplated for use as the sterile connection arrangement 30a-b in the blood processing apparatus 12 described above, but sterile connection arrangements based on other operating principles may also be employed.

Further, as shown in fig. 1A and 1B, the illustrated processing device 12 includes a scanner 36 associated with and facing each receptacle. Each scanner is configured to view or read a bar code and/or other information on the facing side of a particular container (e.g., on a label) and to communicate the information contained or encoded in the bar code, an image of all or a portion of the label, and/or other information to a device processor and/or a local or remote data management system for recording as part of process recording, tracking, and/or quality control purposes. Information may be communicated in any suitable manner, and the device may be configured to communicate information via a direct wired connection, the internet, a LAN, WIFI, bluetooth, or other suitable communication means. The imager may also read or image other information on the container or on the container label, as described below.

Blood container

Turning now to different and independent aspects of the present subject matter, FIG. 2 depicts a single whole blood collection container and tubing set or module. The container 80 is formed from a pair of facing flexible plastic films or sheets 82, which flexible plastic films or sheets 82 may be made from any suitable heat sealable material, such as, but not limited to, polyvinyl chloride. The container has an interior cavity with a first end 84, an opposing second end 86, a first side 88, and an opposing second side 90. The sheets are sealed together, for example by Radio Frequency (RF) or heat sealing, along a sealing line 92 which extends around the entire periphery of the container and is uninterrupted except for an inlet port 94 and an outlet port 96 at the first end of the container cavity. The location of the ports may vary, but in the illustrated embodiment the inlet port 94 is between the outlet port of the container and the second side 90, and is preferably substantially adjacent the corner or junction between the first end and the second side. The outlet port 96 is shown generally midway between the first and second sides. Alternatively, it should be noted that the ports 94 and 96 may be either inlet or outlet ports depending on the intended use.

The inlet port 94 is connected to an inlet flow conduit 98, the inlet flow conduit 98 extending to a pre-attached venous access device 100, such as a needle, or to a connector for connection to a needle, such as a standard luer lock. The inlet flow conduit 98 may have additional ports or connection locations as desired, such as for pre-donation sampling, etc. It may also include an internal frangible valve 102, which internal frangible valve 102 normally blocks flow through the conduit and can be opened by manually manipulating or bending the conduit, as disclosed in U.S. patent nos. 4,386,622, 4,181,140, and 4,270,534, all of which are incorporated herein by reference.

An outlet fluid flow conduit 104 extends from the outlet port 96 to a sealed distal end 106. The length of tubing 104 is sufficient to extend from container 80 to an aseptic connection device, such as aseptic connection device 30b, located on processing device 12. Although the length may vary depending on the configuration of the device 12 to extend through the illustrated hematocrit sensor 34 and clamp 32a and to the sterile connection device 30a, a length of about 10-20 inches (25.4-50.8cm), for example 13-14 (e.g., 13.5) or 17 inches (33.0-35.6 (e.g., 34.3) or 43.18cm) may be used for the arrangement shown. The use of an outlet conduit separate from the inlet conduit helps prevent blood clots from entering the downstream processing module or system if the user cannot discharge any blood remaining in the inlet conduit (also referred to as stripped blood) into the container at the time of collection.

A hanging hole (shown for purposes of illustration and not limitation as a slit 108) is provided in the sealing line 92 to allow hanging of the container, such as on a scale hook used in the processing device 12. The slit 108 in the second end 86 of the container 80 allows the container to be hung vertically and the slit along the side of the container allows the container to be hung such that it is hung in a direction other than vertical, such as horizontally or at a downward angle as shown in fig. 2, with the inlet port 94 being slightly lower than the outlet port 96 by a distance D. Hanging in this position allows any solids (e.g., clots) in the collected blood to settle out of the outlet port and helps to avoid such solids from clogging the outlet flow conduit 104 or being introduced into downstream processing system components.

The number and location of the slots 108 may vary. Although in fig. 2, two slits are shown on each side of a container having a single end slit, a single slit may be used on one or both sides, and such slits may be centered or off-center. The end slits can be eliminated to allow only non-vertical suspension. Alternatively, the side slits may be omitted and only a single end slit used for containers limited to vertical suspension. Providing a plurality of slits as shown in fig. 2 allows the user to select a desired suspension position.

Fig. 3 shows an integrated container system 110 having two discrete container cavities: an additive solution chamber within container 112 and a whole blood collection chamber within container 114. The chambers or containers are integrally joined by an intermediate web 116.

The integrated container is formed from two facing flexible plastic sheets or films that are sealed together, such as by RF or heat sealing. Each container is defined by a separate seal line and is of generally rectangular configuration having opposite ends and sides. The additive solution container or cavity 112 is formed by a seal line 118 extending along a first end 120, a first side 122, a second end 126, and a second side 128. The sealing line is uninterrupted except for an outlet port 130 and an inlet port 132 in the first end of the container. An inlet port allows additive fluid to be added to the container 112 during manufacture, and an outlet port 130 is attached to a length of fluid flow tubing 134 sealed at the distal end for connection (preferably sterile connection) to processing equipment or modules.

The whole blood container or chamber 114 is formed by a seal line 136 extending along a first end 138, a first side 140, a second end 142, and a second side 144. The seal line is uninterrupted except for an outlet port 146 and an inlet port 148 in the first end of the container. The inlet port allows whole blood to flow in during collection and the outlet port directs fluid flow to downstream processing equipment or modules. The inlet port also allows anticoagulant solution to be added to the container during manufacturing. An inlet flow conduit 150 extends from the inlet port and an outlet conduit 152 extends from the outlet port. The inlet and outlet conduits 150, 152 may be configured similarly to the inlet and outlet flow conduits 98, 104 described previously with respect to the vessel in fig. 2.

The first side 122 of the additive solution container 112 is attached to the second side 144 of the blood container 114 by an integral intermediate web 116, the intermediate web 116 being part of the original plastic sheet used to form the container and extending between the containers. The web may have a desired width and allow the container to be folded into a more compact arrangement for transport or handling, if desired.

Identification/tracking

Fig. 4-6 relate to another independent aspect of the present subject matter-systems and methods for identifying and tracking blood and blood components. FIG. 4 is a flow diagram that illustrates devices and steps employed in one embodiment. An exemplary blood container 160 in the form of a bag or pouch is shown at the top of fig. 4, and may be, for example, the single container of fig. 2. First panel or label 162 is substantially permanently pre-attached to the exterior surface of the container. The second panel or sticker 164 may be smaller than the first panel and peelably pre-attached to the outer surface of the first panel. The first panel has an outer edge or first panel perimeter (defined by its side edges 1S and end edges 1E, respectively), and the second panel may be smaller so as to fit completely within the first panel perimeter. The surface of the first panel underlying the second panel may include a release surface that allows removal of the adhesive-backed second panel, or the second panel may use a peelable adhesive to releasably attach to the first panel.

As shown in the second step in fig. 4, a third panel or label 166 is permanently attached to the second panel, as by a technician or phlebotomist, at or before the actual collection of blood in the container 160. The third panel includes a plurality of removable uniquely coded Donation Identification Number (DIN) identification panels (such as stickers) 168 that may be used to identify a particular donation and track the source of blood components from the donation. The second panel has an outer edge or perimeter defined by its side and end edges 2S and 2E, respectively, and the third panel may be smaller than the second panel and sized to fit entirely within the second panel perimeter. Similarly, the identification panel may be sized to fit completely within the perimeter of the third panel (also defined by the side edges 3S and end edges 3E, respectively, of the third panel). In the next illustrated step, during post-collection processing, when the red blood cells are concentrated and transferred into another container 170, the second panel 164 (with the third panel and DIN panel attached, such as a sticker) is removed from the whole blood container and placed and attached to the concentrated red blood cell container 170. The red blood cell sample may be removed from the red blood cell container for later blood group verification or other testing into a sample container 172, such as a tube or vial, as shown in the final step of fig. 4. At this point, one of the DIN identification panels, e.g., a sticker, may be removed from the panel on the red blood cell container and may be permanently attached to the sample container, thereby maintaining traceability of the blood sample. The second panel may include a release surface that allows removal of the adhesive backed DIN identification panel, or the DIN panel may use an adhesive that is releasable from the third panel.

Fig. 5 shows an alternative arrangement and sequence. In this alternative, the whole blood container 160 does not have the first panel 162 and the second panel 164 pre-attached to the container. Rather, for convenience, the first and second panels are separately pre-attached together, and the first panel is permanently affixed to a surface of the blood container prior to or at the time of blood collection. At this point, as described above, the third panel 166, having the DIN identification panel (e.g., sticker) 168 thereon, is permanently attached to the second panel to allow the remaining steps discussed above to be performed and to remain traceable.

Another alternative is shown in fig. 6, which is similar to fig. 5, except that the second panel itself is subdivided into DIN identification panels or labels that are pre-printed and can be removed or peeled away (e.g., from a peel-off layer or by using a peelable adhesive) to attach to sample tubes or vials. This eliminates the need for a separate third panel of DIN label permanently attached to the second panel.

Blood container/identification with two-dimensional bar code

Turning now to another independent aspect of the present subject matter, FIG. 7 illustrates a particularly effective arrangement for information transfer and recording. An example of a general type of blood or blood component container 180 is shown, such as the single container of fig. 2 discussed above. A two-dimensional barcode 182 is located on the container and may contain important information useful in tracking and quality control and may be scanned by a scanner 184. Currently, relevant regulatory agencies allow information to be placed in specific locations on containers. For some types of information, it is desirable to space the information far enough apart or on different sides of the container and not be readable or scannable by a single imager or scanner in a fixed location on the processing instrument. An example of this is the manufacturer's part or catalog number (perhaps on the back of the container) and the product expiration date (perhaps in the lower right hand corner of the front of the container).

Two-dimensional barcodes have the ability to store large amounts of information, far beyond typical one-dimensional or linear barcodes. According to this aspect, a two-dimensional bar code is employed that contains the relevant manufacturer's data in a location on the container or container label that preferably faces or is visible from a stationary scanner 184 on the processing device, similar to the scanner 36 shown in fig. 1A and 1B. "two-dimensional barcode" is not limited to a particular code format, specification or standard, but is intended to be a generic term used in its ordinary sense that refers to a two-dimensional representation or matrix containing or encoding information based on dark and bright spots or areas and bright areas within the matrix, which is typically, but not exclusively, square or rectangular, and which is distinct from a one-dimensional barcode based on a series of lines and spaces. The stored or encoded information may include, alone or in any desired combination, any of, but is not limited to, the manufacturer's part or catalog number, lot number, expiration date of the container or module, product code of the blood product to be contained in the container, and other such information. It may be particularly advantageous to encode the part or catalog number alone or in combination with the product expiration date. Alternatively, the bar code may include any additional manufacturer information required by the U.S. industry consensus standard for uniform identification of blood and blood components. This does not preclude the required information from being present elsewhere to meet regulatory requirements, but encoding this information into a single two-dimensional barcode allows a single scanning device to automatically read/image all of the information without user manipulation so that it can be retained as part of a stored process record.

In another independent aspect of the present application, fig. 8 diagrammatically depicts a blood container 190, the blood container 190 carrying a commercial logo or identifier 192 having a unique design or configuration associated with a particular source, the commercial logo or identifier 192 being scannable by a scanner 194 to determine and authenticate that the disposable item is genuine and is the product it purports to be (in this case, the product of the particular source), in which case the Fenwal corporation "commercial logo" as used herein is intended to be generic and may include any design and/or number or combination of letters or designs consistent with the particular source of the product. The commercial logo may include a registered trademark, but is not limited thereto.

More specifically, a processing device employing such a system may include a programmable control processor and an on-board data store, look-up table, etc. (or access to a remote data store) of selected characteristics of such a commercial logo on an authentic container (e.g., an authentic Fenwal blood component container). Such features may be any one or more of a number of aspects, including but not limited to one or more features such as location coordinates of the logo on the container, spacing between certain numbers or letters contained in the logo, font or image size, size ratios of certain aspects (such as ratios of different font sizes), image density or ink density on certain portions of the logo, logo image resolution, and logo ink material. The detected characteristics of the container under consideration will be compared with the stored reference characteristics of the logo on the genuine product, and based on this comparison, the controller will determine whether the detected characteristics and the stored characteristics are the same or sufficiently the same. So that the product in question is considered genuine. If not, the controller may generate an alarm state or an alert state, such as an audio signal, visual signal, or other signal, or even disable operation of the treatment device prior to operator intervention.

The scanner 194 of the present application may be separate from the barcode scanner described above, or may be combined into a single scanner or scanning unit, such as the scanner 36 on the processing device of fig. 1A-1B, if feasible. As with the two-dimensional bar code described above, the commercial logo 192 is preferably located on the surface of the container or container label facing the processing device when the container is suspended from the processing device, so that the logo can be automatically scanned without user manipulation.

Fig. 9 diagrammatically illustrates positioning of a scanner/imager in a medical fluid processing device, such as the blood processing device 12 of fig. 1A-1B. As shown in the partial view of fig. 9, the treatment device has a housing 200, the housing 200 having a wall 202 and an aperture in the wall forming a window 204. The window is located near where a container 206 (such as a blood or blood component container, additive solution container, or other container) will hang when suspended from a hanger 208 or other hanging member (e.g., a clamp) on the processing device. The window 204 is preferably made of glass that shields electromagnetic interference. The scanner 210 is located within the housing 200 behind the window 204. A similar configuration can be seen in fig. 1A-1B, where the scanner 36 is located on the processing device behind and facing each of the receptacles 40, 44, 52 and 54.

The scanner 210 may be of any suitable design or employ any suitable technique to scan, image or otherwise capture the two-dimensional barcode, logo and/or blood container label as described herein. For example, the scanner 210 may employ a laser, a camera, a CCD scanner, or other suitable imaging or scanning device or technique. One non-exclusive example of an imager/scanner that may be used herein is a JE-227 type scan engine or similar device from Jadak Technologies, Inc., having an office in North Standholtz, N.Y..

As described above, the scanner 210 is preferably mounted within the housing 200 for protection and positioned to optically view or scan the container 206 through the window 204. The scanner is positioned such that it scans or images a particular surface area of the container. More particularly, with respect to the present subject matter, the scanner is preferably positioned to image a label 212 on the surface of the container facing the window, the label having information to be recorded as part of a process record. The information may be in the form of or encoded in a bar code (e.g., the two-dimensional bar code discussed above) and/or a commercial logo. In the medical field in general and in the field of blood collection and processing in particular, aspects of the containers and container labels may be subject to specific requirements of regulatory or standards-setting agencies. Typically, labels on containers for blood or blood components are rectangular and have dimensions of about 4 inches (102mm) in width and 4 inches (102mm) in length. The IS03826 standard shows a label for a blood component container having a label size of 105mm x 105mm (4.1 inches x 4.1 inches). The labels may also need to conform to other standards such as ISBT-128, ST-005, which require the container to carry a Base Label (Base Label) of 100+/-2mm by 106+/-2mm (3.9 inches by 4.2 inches). Thus, these tags are typically within a space of 4+/-0.25 inches by 4+/-0.25 inches. For purposes of this specification, the above labels, even if slightly larger or smaller, are considered to be substantially 4 inches by 4 inches.

Advantageously, the scanner 210 in the illustrated embodiment is configured to image the entire or substantially the entire label 212, including a bar code, such as a two-dimensional bar code, for product information recording (if present on the label) and a commercial logo for authentication purposes. To achieve this, the scanner is specifically positioned within the housing. In the illustrated embodiment, the scanner 210 has a field of view 214 (which may have a vertical orientation and a horizontal orientation — only the vertical orientation is shown in FIG. 9) and a focal length or distance 216. To image a desired surface area of a blood or blood component label having a label area of about 4 inches by 4 inches, a scanner having a vertical field of view of about 30-40 degrees and an equal or greater horizontal field of view may be positioned about 6-8 inches (about 15-20cm) from the surface of the suspended container. This configuration may vary based on the size of the particular region to be imaged and the particular scanner employed without departing from this disclosure. As previously mentioned, one non-exclusive example of a scanner that may be used in the present subject matter is the JE-227 type scanning engine or similar device available from Jadak Technologies, Inc. having an office in North Staratholz, N.Y..

While various independent and related aspects of the present subject matter have been described with reference to specific illustrated structures and methods shown in the accompanying drawings, it is to be understood that the present subject matter is not limited to such specific structures or methods, and that it may be applied to other forms and apparatuses without departing from the scope of the present disclosure. Accordingly, reference should be made to the appended claims for purposes of determining the scope of the present subject matter.

Claims (11)

1. A durable blood processing apparatus for cooperative association with a disposable blood or blood component processing circuit including a plurality of individual processing circuit modules for cooperative mounting on the processing apparatus, one of the modules including a rotatable blood separator, and the processing apparatus including a receiving station for the rotatable blood separator and a drive system at the station for rotating the blood separator, and at least two of the processing circuit modules including thermoplastic fluid flow conduits, and the processing apparatus including sterile connection means for receiving the conduits of the at least two circuit modules and automatically connecting the conduits to one another in a sterile manner upon activation of the apparatus by a user, to enable fluid flow through the conduit.

2. A durable blood processing device according to claim 1, wherein the sterile connection device severs the sealed end of each of the tubes and fusion bonds the open ends of the tubes together while maintaining the interior sterility of the tube segments.

3. A durable blood processing device according to claim 1, comprising: a housing; a container suspension device for suspending a container from the processing device; and a scanning system for scanning at least a portion of a surface of a container facing the suspension device when the container is suspended from the suspension device, the scanning system comprising:

a window in the housing adjacent the location of the container when suspended from the suspension means; and

a scanner located within the housing and positioned to scan a selected surface of a suspended container through the window.

4. The durable blood processing device of claim 1, wherein the scanner has a field of view and is positioned within the housing so as to be a selected focal distance from a surface of a suspended container to be scanned, such that the field of view includes substantially the entire selected surface area.

5. A durable blood processing device according to claim 3, wherein the selected surface area is substantially the size of a label on the container.

6. The durable blood processing device of claim 3, wherein the window comprises electromagnetic interference resistant glass.

7. A durable blood processing device according to claim 3, wherein the selected area comprises a generally rectangular area having a length and width substantially corresponding to container label dimensions of the suspended container as required or suggested by regulatory or standards-making agencies.

8. The durable blood processing device of claim 3, wherein the selected area comprises a generally rectangular area having a length of substantially 4 inches and a width of 4 inches.

9. The durable blood processing device of claim 8, wherein the rectangular area is substantially a label size required or suggested by ISO3825 for a container of blood or blood components.

10. The durable blood processing device of claim 3, wherein the scanner is positioned about 6 to 8 inches from a surface of the hanging container to be scanned.

11. A durable blood processing device according to claim 10, configured to store or transmit information scanned from the selected surface.

Images